NCT05032820 · OUTCOME

Exploratory Objective 2: Immune Reconstitution (WBC)

Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma · Source last updated 2026-05-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: x10^3 cells/uL
Interval / dispersion: Standard Deviation
Time frame: Pre-LD chemo, Day 30, 90, 180, 365

What was measured

The cellular composition of marrow (WBC Count) will be quantified at the specified timepoints by flow cytometry.

Analysis population: Participants who received an infusion

Groups in this outcome

Lenalidomide and bb2121

Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells. Cyclophosphamide: 300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Lenalidomide and bb2121	38

Reported measurements

WBC count pre-LD chemo

Values in x10^3 cells/uL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and bb2121	10.69	15.61	Not reported	Not reported	Not reported

WBC count day 30

Values in x10^3 cells/uL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and bb2121	6.09	8.43	Not reported	Not reported	Not reported

WBC count day 90

Values in x10^3 cells/uL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and bb2121	7.61	15.22	Not reported	Not reported	Not reported

WBC count day 180

Values in x10^3 cells/uL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and bb2121	6.11	5.75	Not reported	Not reported	Not reported

WBC count day 365

Values in x10^3 cells/uL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide and bb2121	6.96	11.61	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
15.61
value
10.69
title
WBC count pre-LD chemo
categories
measurements
group Id
OG000
spread
8.43
value
6.09
title
WBC count day 30
categories
measurements
group Id
OG000
spread
15.22
value
7.61
title
WBC count day 90
categories
measurements
group Id
OG000
spread
5.75
value
6.11
title
WBC count day 180
categories
measurements
group Id
OG000
spread
11.61
value
6.96
title
WBC count day 365

denoms

counts
group Id
OG000
value
38
units
Participants

description

The cellular composition of marrow (WBC Count) will be quantified at the specified timepoints by flow cytometry.

dispersion Type

Standard Deviation

groups

description
Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells. Cyclophosphamide: 300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis
id
OG000
title
Lenalidomide and bb2121

param Type

MEDIAN

population Description

Participants who received an infusion

reporting Status

POSTED

time Frame

Pre-LD chemo, Day 30, 90, 180, 365

title

Exploratory Objective 2: Immune Reconstitution (WBC)

type

OTHER_PRE_SPECIFIED

unit Of Measure

x10^3 cells/uL

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Preserved source evidence · Not medical advice